Background: Exercise is known to improve mental and physical
functioning and to improve quality of life. The obstacles faced by
individuals with chronic kidney disease on maintenance haemodialysis
include increased levels of fatigue, decreased motivation, and the
inability to schedule exercise around daily activities and dialysis
schedules.

Aim: This pilot study was undertaken to determine the feasibility
and potential efficacy of an individually-tailored exercise program for
in-centre haemodialysis patients.

Method: A 16 week program was designed and evaluated in relation to
changes in physical capacity, the extent of exercise undertaken, and
quality of life indicators.

Results and Conclusion: The resultant recommendations regarding the
level of motivational support, the time and physical requirements in
implementing an exercise program will provide useful information for
others embarking on similar studies.

Haemodialysis (HD) patients' quality of life (QoL) is
significantly impaired in comparison to the healthy population, and
those who have received a renal transplant (Cheema & Singh, 2005).
This is often attributed to high levels of fatigue, which encompasses
physical and mental exhaustion, reduced motivation and reduced activity
(McCann & Boore, 2000 & Kutner, 2007). Despite patients commonly
having poor exercise tolerance, some form of exercise is believed to
improve physical and mental functioning in dialysis patients and thereby
enhance their QoL (Moug et al, 2003; Painter et al 2004; Bennett et al,
2007).

The physiological benefits and the QoL impact of intra-dialytic
exercise are still a matter of debate. Some authors suggest no changes
result after commencing an intra-dialytic exercise program (Parsons et
al, 2004) whilst others note improvements (Cheema & Singh, 2005;
Painter et al, 2000). At a minimum, it appears that intradialytic
exercise may provide a supportive supervised environment where
additional encouragement and counselling are available (Painter et al,
2000). Unfortunately there are difficulties involved in implementing and
sustaining exercise programs (White & Grenyer, 2006), with the
greatest challenges pertaining to the maintenance of an 'exercise
culture' (Bennett et al, 2007). It is also difficult to maintain
patient motivation in the longer term, given the known link between
fatigue, motivation and depression (Kutner, 2007; Molsted et al., 2004).

It has been demonstrated that intra-dialytic exercise can be
effective in people with chronic kidney disease (CKD) (Bennett et al,
2007; McMurray et al, 2008). We examined these studies to inform the
development of an exercise intervention in HD patients. Specifically,
this current study was to determine the feasibility of implementing a 16
week exercise intervention for haemodialysis patients in our setting,
and to determine if the chosen tools were sensitive to the detection of
fatigue and QoL in this group of patients. Our experiences in
implementing an intradialytic exercise program in a large tertiary
hospital are discussed, identifying strategies for success and pitfalls
to avoid. If such programs are to succeed, they need to be well planned
and extensively resourced in order to support long-term sustainability.

Method

Participants

The population of interest for this study were medically stable
haemodialysis (HD) patients from a chronic dialysis unit in Queensland,
Australia. Our sample was drawn from an in-center HD unit in Brisbane
which currently treats a total of 110-115 chronic dialysis patients, and
equates to approximately 50-55 patients per day. In keeping with the
feasibility focus of the study, the aim was to recruit only a relatively
small sample of 15 participants. All patients who met the following
inclusion criteria were invited to participate: attending in-centre
haemodialysis three times per week; had been treated with haemodialysis
for more than three months (Cheema & Singh, 2005); received medical
clearance by the Renal Consultant to participate; able to read and write
English to complete questionnaires; and had a serum phosphate level
greater than 1.6mmol/ litre on three consecutive occasions. It was
initially proposed these patients may benefit the most from exercising,
and would provide a feasible workable number for this pilot study,
considering resource and equipment restrictions. Patients were excluded
if they had evidence of recent myocardial infarction, uncontrolled
hypertension, unstable angina, severe uncontrolled diabetes, symptomatic
left ventricular fibrillation, neurological or cognitive disorders with
functional deficits, musculoskeletal problems, in line with previously
published criteria (Cheema & Singh, 2005). The study was approved by
the Human Research Ethics Committee of the facility, and informed
consent was obtained from all participants.

Intervention

All participants underwent an individualized tri-weekly
intra-dialytic timed pedal exercise program using a bicycle ergometer
for 16 weeks. Several bicycles were already present within the unit but
were not being utilised, for economic and practical reasons it was
considered more feasible to continue with this type of equipment.
Participants were assessed four weeks prior to, prior to and immediately
following the exercise intervention. Participants were reviewed weekly
by a physiotherapist to individualize the exercise program.

Exercise was scheduled within the first two hours of dialysis in
order to encourage motivation and prevent hypotension (Parsons, 2004;
Martin & Gaffney, 2003). Most participants exercised between 2 and
15 minutes, had a 5-10 minute rest, and then exercised for another 2 to
15 minutes dependent on their individualised program, while some
exercised for 30 minutes continuously. An 'exercise nurse'
familiar with the proposed trial was allocated to exercising patients on
each shift and participants were verbally reminded at commencement of
dialysis regarding their exercise program, and an alarm clock was used
to time the exercise period.

Outcome measures

The feasibility of conducting an intra-dialytic exercise program
was determined by ease of recruitment and completion rates. The effect
of the intra-dialytic exercise program was measured using fatigue, QoL
and functional capacity [six minute walk test (American Thoracic
Society, 2002) and timed sit-to-stand (Csuka & McCarthy, 1985)]. In
addition, certain measures were undertaken throughout the study period
to monitor progress. In this study, the MFI-20 was administered
fortnightly, and the EQ-5D monthly. These time frames were chosen in
order to achieve a balance between an adequate number of time points
needed to provide valid longitudinal data whilst maintaining patient
interest.

(i) Fatigue was measured using the multi-dimensional fatigue
inventory (MFI-20) prior to the commencement of the exercise program, to
determine the patient's baseline fatigue level, and fortnightly
during the exercise program to determine the impact of exercise on
perceived levels of fatigue. The MFI-20 has a five-point response Likert
scale ('1--yes that is true' through to '5--no, that is
not true') to indicate the degree of agreement to each of the nine
statements with higher scores indicating greater fatigue levels. Fatigue
was categorised into the following components: general fatigue,
physical, reduced motivation and mental. The scale is parsimonious and
simple to complete. The MFI-20 has been used across diverse population
groups, and has established reliabilities of 0.86 (group level) to 0.90
(individual variations) (Smets et al, 1995).

ii) Quality of life was measured using the EQ-5D Health
Questionnaire (2006) prior to and monthly during the intervention
period. This tool measures quality of life across five dimensions
including mobility, self-care, usual activities, pain and discomfort,
and anxiety and depression. For each dimension participants selected
from the following response options; "no problems",
"moderate problems" or "severe problems". This
results in a possible 243 various combinations with pre-determined
weightings. Additionally, the questionnaire contains a visual analogue
scale (VAS) that asks participants to indicate how "good" or
"bad" their health is 'today'. The anchors for the
VAS are "0" (worst imaginable health state) to "100"
(best imaginable health state). This scale has been used extensively in
patients with CKD as a measure of general health and generic
health-related QoL (Gerard et al, 2004). The EQ-5D is well suited to
patients with major morbidity, despite its relative insensitivity to
variations in well-being at the upper ends of the health continuum
(McDowell, 2006). Higher response rates and less missing data has been
seen with EQ-5D than other QoL tools, and hence our rationale for
inclusion (Gerard et al, 2004).

iii) Functional ability was measured using the six minute walk test
(American Thoracic Society, 2002) and timed sit-to-stand (Csuka &
McCarthy, 1985) by the physiotherapist prior to, and immediately
following the exercise program in line with like studies (Painter et al,
2000; Headley et al, 2002).

iv) The dietary assessment was undertaken prior to, mid-way, and
immediately following the intervention to assess variances in
nutritional intake and status.

Data Analysis

Recruitment and completion rates were calculated to determine the
feasibility of the study, and the exercise intervention was evaluated
based on response rates, scale scores, means and standard deviations of
chosen tools.

Results

Feasibility of intra-dialytic exercise

The study was expected to take 6 months to complete; however, it
took more than 6 months to recruit participants. We expected a
manageable 'pool' of 15 participants; however, only a small
percentage of the total patients of the unit had consistently elevated
phosphate levels (greater than 1.6mmol/L). Thirteen participants were
recruited to the study, two of whom withdrew from the study after
completing several weeks of the exercise program for personal reasons.
Of the group 58% were male, with an average age of 54 yrs (SD 21.6),
Demographics are outlined in Table 1. Of the remaining 11 (85%)
participants who completed the exercise program, two were unable to
complete the post program assessment due to medical reasons. In
addition, one participant was transferred to peritoneal dialysis after
completing 10 weeks of the exercise program. This participant's
post program assessment was undertaken at this stage and included in the
analysis. During the recruiting period, two patients met the inclusion
criteria but declined to be involved, five additional patients consented
but later declined to commence exercise program, three for personal
reasons and two as they received renal transplants.

Effect of intra-dialytic exercise

Only data from pre and post assessments for fatigue and QOL have
been included as there were numerous missing data points from the
planned fortnightly collection points. Mean (MFI scores at baseline
ranged from 8 (SD 5) for mental fatigue to 13 (SD 5) for reduced
motivation, indicating that a moderate degree of perception of fatigue
was experienced by most participants across all components. There was no
difference in MFI 20 scores following the exercise intervention for any
fatigue component (p > 0.11). The EQ5D again showed a 73% complete
response rate (8/11), with 4 participants showing improvements, 2
showing nil changes and 2 participants noting a decreased quality of
life. The VAS noted a 64% complete response rate (7/11), with 5 showing
improvement, 1 nil change and 1 decreased (participant who withdrew
because of a declining medical condition). Due to the small sample size
and lack of completeness in survey returns, no trends can be verified
from our data.

Of those recruited (n = 13), the overall compliance rate with the
exercise program was 73%. In other words, 73% of the prescribed exercise
sessions (13 x 3 sessions/ week x 16 weeks) were completed. However,
with consistent support of physiotherapist and nursing staff, 85% of
participants completed the exercise program. One patient experienced
thigh cramps and required to change to elastic band stretching exercises
instead of the bicycle ergometer. Reasons for missed sessions include
medical reasons, equipment being unavailable, cramps (which may be
related to dialysis [Daugirdas et al, 2007]) and other musculoskeletal
soreness, and inadequate reporting of completed exercise sessions. No
other adverse effects were reported by patients or were physically
evident during the trial. The average (SD) time spent exercising in each
session increased from 9.9 rnms (4.4) in Week 1 to 29.2 rmns (7.4) in
Week 16.

Intra-dialytic exercise has been shown to increase exercise
capacity including distance covered and sit to stand ability (Painter et
al, 2000; Headley et al, 2002). In the current study 5 participants
showed an increase in exercise capacity, 3 remained unchanged, and 1
decreased. The distance walked in 6 minutes improved by an average of 20
metres (95% CI -5 to -31) following the completion of the exercise
program. There was no significant difference in the time required to
complete 5 sit-to-stands.

Discussion

This study endeavoured to determine the logistics and feasibility
of implementing an exercise program, and found there were significant
challenges. This included time constraints, difficultly in maintaining
participant motivation, and length of data collection. Most
intra-dialytic exercise programs ranged from three to six months, with
positive effects after 12 weeks, and a peak effect at 16 weeks, hence
the reason for chosen program length (Cheema & Singh, 2005).
Anecdotally, the participants were very positive to other patients about
the trial but this dwindled as time progressed and the perceived
benefits of exercise were not evident on a personal basis.

Despite the small sample size, 76% of the recruited participants
completed the program which was extremely positive considering the
literature identifies compliance rates ranging from 43% to 99% (Cheema
& Singh, 2005; van Vilsteren et al, 2004), however, these figures
were only reported in 31% of studies on this topic (Cheema & Singh,
2005; Koufaki et al, 2002). The drop out rate was 15%, which was a
significant decrease from the drop out rates of 51% that had previously
been reported (Cheema & Singh, 2005).

Equipment cost and availability meant that only three participants
could be actively exercising at any one time, and scheduling of
equipment dependent on dialysis session times, meant that participants
had to commence the study in scheduled intakes. This sample size was
congruent with previous studies with 45% containing up to 20 patients
(Cheema & Singh, 2005).

In-centre exercise programs are recommended because of the
available support, the ability to integrate exercise whilst otherwise
"occupied" and by reducing the period in "forced
inactivity" (Kutner, 2007). To support this on a weekly basis,
patients were reviewed and motivated by the physiotherapist, whilst the
nurse investigators also discussed patient progress on a bi-weekly basis
as well as individual staff members prompting exercise commencement at
each visit. Patients appeared to enjoy the novelty of the
'bicycles' and additional attention and reviews from nursing
and physiotherapy staff, which provided distraction from routine
dialysis regimes. Recruitment and support updates were promoted in a
patient newsletter, as a strategy to prevent inactivity due to the
possible negative influence of others that were not participating as
advocated by Painter et al (2004).

The Pedal exercise programs have been shown to increase exercise
capacity, measured by distance walked and functional ability
(sit-to-stand movement speed) (Cheema & Singh, 2005; Painter et al,
2000; Headley et al, 2002). The amount of change observed in exercise
capacity was not dependent on the average session duration (p = 0.57) or
total numbers of sessions completed (p = 0.17). Tailoring programs to
patient preferences and capabilities is seen as a method of recruitment
(McMurray et al, 2008) and also has been reported to be useful for
providing additional motivation (Painter et al, 2000, Molsted et al,
2004). Greater improvements in physical functioning and possible higher
levels of participation have been noted in programs that have frequent
interaction with exercise professionals rather than programs solely
monitored by dialysis staff (Painter et al, 2000; Oh-Park et al, 2002;
Goodman & Ballou, 2004; van Vilsteren et al, 2004). To establish
feasibility of an ongoing exercise program, visiting support by the
physiotherapist was considered the most physically and financially
sustainable approach. Involvement of exercise experts with skills and
experience to motivate and coach patients and staff have been noted as
being highly beneficial in successfully adopting an exercise programme
(Bennett et al, 2007). Whilst the allocated exercise nurse provided
additional support and encouragement during exercises, their roles were
prioritized related to clinical needs of the unit and patients were more
likely to view the nurse in that role than purely as an exercise
motivator.

Evaluation measures

Despite strategies to ensure surveys were completed and returned,
missing data throughout the study period seem to be unusually high in
this population. Therefore a reduction of collection points to monthly
or at commencement and completion of study is recommenced. If data
periods were reduced to take into consideration only pre and post
results, response rates are predicted to be to 58 to 67%, although
previously noted response rates with questionnaires have been as high as
75% (Painter et al, 2004). Reasons for poor response rates in this
population are uncertain but may be attributed to the increased
likelihood of being surveyed as part of a teaching hospital. Completion
time was also longer than the anticipated 10 minutes, as some patients
required information to be read to them or required assistance to
complete due to having restricted hand movement during dialysis.

Participants were already on a high protein high energy diet, were
not malnourished and dietary intake remained stable. Little change was
expected; therefore dietician assessments are not routinely required
when active exercise programs are in place, unless malnutrition is
suspected.

Limitations

We acknowledge that this study has several limitations,
particularly in relation to sample size and required resources. Small
sample size was utilised to address the initial purpose in establishing
the feasibility of implementing an in-centre exercise program. As our
sample was drawn from an in-centre site, participants were likely to be
'sicker' and more debilitated, which may have influenced their
level of participation. In relation to resource availability, budget
constraints limited allocated research nurses' time to one
day/fortnight after initial planning and patient identification. This
was not a sustainable method of ensuring timelines and project goals.

Recommendations

The fiscal, environmental and time constraints evident in a large
tertiary hospital make the addition of a patient focussed physical
activity program very challenging. Although authors such as Bennett et
al. (2007) found that exercise programmes can be adapted to HD settings,
this is highly variable dependent on the capacity and workload of the
unit, with our unit finding evaluating and sustaining a program over the
longer term, unachievable. Larger multi site studies are recommended to
establish the on-going feasibility of individualised exercise
programmes.

Future research should include the allocation of physiotherapy
services and the appointment of a daily exercise nurse, as weekly
"in-depth" attention, that was able to be provided is not
enough to sustain motivation. The initiation of physiotherapy services
for outpatients receiving dialysis was a positive endeavour, and
assisted in providing a perspective of additional health promotion and
professional advice that was previously unavailable. The in-centre
dialysis population typically are faced with physical or social
challenges that prevent them from undertaking home-based therapy--the
effect of this additional support cannot be underestimated. An
environment conducive to self-care, independence and, active
participation is seen as the ideal place to instigate in-centre exercise
programs.

Conclusion

Exercise has been established as a vital component of health
promotion activities for all, especially those with renal disease.
Short-term exercise programs show varying results dependent on the
extent of fatigue, quality of life and impact of disease. The
culminating effects of these is difficulty in maintaining motivation in
the medium to long-term, especially when faced with a chronic disease
and benefits may not become evident. Structured and supported exercise
programs require a committed team, resources and appropriate environment
to foster a shift in thinking towards self-care and activity.

Acknowledgements

The Office of the Chief Nursing Officer, Queensland Health,
provided financial assistance for this research.

The researchers also acknowledge the Haemodialysis Unit nursing
team members and patients, physiotherapy researcher Suzanne Kuys,
dietician Eryn Murray, research assistant Judy Batkin and data manager
Kylie Hurst who gave of their time to assist in the study.